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More than a promise!

Hyabell®

• immediately visible• natural and long lasting results

• for various indications in the dermis and subcutis• less pain

The new range of HYABELL® dermal fillers offers a long lasting improve-ment and a convincing safety profile. The pre-incorporated lidocaine (0.3%)facilitates the injection procedure and reduces significantly the pain andfinally enhances patient’s satisfaction.

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Skin levels and optimalinjection depths

Product LIPS BASIC DEEP ULTRAPurpose Wrinkle Treatment Volumisation

Total HA concentration 12mg/ml 16mg/ml 20mg/ml 24mg/mlLidocain concentration 0.3% 0.3% 0.3% 0.3%Crosslinking agent BDDE BDDE BDDE BDDE

Volumising effect

Volume / Packaging

•••middle to

deep dermisdeep dermis / hypodermis

hypodermis / epiperiostal

1 x 1.0 ml 1 x 1.0 ml 1 x 1.0 ml 1 x 1.0 mlNeedle size 27G 27G 27G 27GEstimated duration 6-9 months 6-9 months 9-12 months 12-14 months

Depth of injection lips muscleand contour line

•••• ••••• ••••••

Indications lip augmentation,lip contour

medium wrinkles,lip contour

deep wrinkles,especially

contour of the face

very deep wrinkles,face contouring,

volumising

Hyaluronic Acid Dermal Filler

3

120

100

80

60

40

20

012 24 36 48 60 72

Benefits of lidocaine Lidocaine is an effective local anesthetic that reduces pain associated withintradermal injections. It is quickly released from the injected hyaluronicacid gel and then metabolised.

HYABELL® is an injectable cross linked hyaluronic acid gel with 0.3% lidocain hydrochloride.

Result of lidocaine release tests demonstrate that in all HYABELL®

products more than 40% of the lidocaine was released after 1 hour andmore than 80% of the lidocaine was released after 4 hours. After 72 hoursa complete release of lidocaine could be stated – which is similar value toother fillers.

Comparison of release profiles of lidocaine HYABELL® Ultra and Mono-phasic - 24 mg/ml gel

HYABELL® ULTRAMono-phasic - 24 mg/ml gel

quantity (%)

time (h)

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Injectability of Fillers with 27G TSK cannula HYABELL® vs. commercial fillers

Excellent InjectabilityHYABELL® provides additional comfort for patient and doctor throughsmooth injectability.

The extrusion force of hyaluronic acid dermal fillers is clinically relevant,because the physician must inject the hyaluronic acid dermal filler througha thin needle into soft tissue. The extrusion force of prefilled syringes canbe determined by means of a testing device according to DIN EN ISO7886-1 (Annex G: Determination of forces required to operate the plunger).

Above chart shows significantly low force and homogeneous extrusion of HYABELL® fillers versus others. The measurements of the extrusionforce were performed with a 27G needle.

60

50

40

30

20

10

0

-10500 1000 1500 2000 2500 3000 3500

ULTRADEEP

injection force (N)

time (seconds)

BASICLIPSMono-phasic - 24 mg/ml gelBi-phasic - 20 mg/ml gelMono-phasic - 25 mg/ml gel

5

0

100

200

300

400

500

600

700

800

ULTRA DEEP BASIC LIPS Mono-phasic24 mg/ml

gel

20 mg/ml + mannitol

gel

16 mg/ml + mannitol

gel

Mono-phasic 24 mg/ml

gel

High viscoelastic properties of HYABELL®

The elasticity and viscosity of hyaluronic acid fillers are directly proportional to their volumising and lifting capabilities of the soft tissue.

Above figure shows the rheological properties of HYABELL® fillers versus commercial fillers available. HYABELL® fillers have greater elastic modulus G´ and viscous modulus G´´ with a better filling effect and a longer duration time in the soft tissue.

The injection results are immediately visible, natural and long-lasting (from 6 up to 14 months).

Comparison of viscoelastic properties (HYABELL® vs. commercial fillers)

Viscous Modules G´´ [Pa]

Elastic Modules G´ [Pa]

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Biocompatibility / SafetyAll appropriate biocompatibility tests have been performed. Biocompatibilityof HYABELL® has been assessed according to the ISO10993: 2009 standards and encompassed all tests.

In addition to the international standard tests, further longer intra-cutaneous reactivity evaluation has been performed with HYABELL® Ultra(24 mg/ml). Results of 12-month implantation tests have demonstratedthat HYABELL® has high tolerance and biocompatibility profile.

Efficacy HYABELL® products with lidocaine are easy to apply, pro viding a com fortable and gentle injection experience according to patients’and doctors’ assessments.

HYABELL® products contain 0.3% lidocaine. For doctors, it facilitates the efficacy of treatments in general.For patients, it improves the comfort by reducing pain, enhancing patients’satisfaction during and after the treatment.

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12 mg/ml hyaluronic acid gel with 0.3% lidocaine

– for lip contouring and lip augmentation

LIPS

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Aesthetic satisfaction1 to 9 months post-injection. Distribution of patients and doctors (%) by level of satisfaction.

% Patient% Doctor

9 months

6 months

3 months

1 months

0 10 20 30 40 50 60 70 80 90 100

Product features Purpose Wrinkle TreatmentProduct name HYABELL® LIPSIndications lip augmentation,

lip contourConcentration 12 mg/ml Lidocaine content 0.3%Crosslinking agent BDDEPackaging 1 x 1.0 ml Needle size 27G Estimated duration 6-9 monthsVolumising effect •••Depth of injection lips muscle

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16 mg/ml hyaluronic acid gel with 0.3% lidocaine

– for middle to deep dermis injection,correction of moderate facial wrinkles and folds

BASIC

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Aesthetic satisfaction1 to 9 months post-injection. Distribution of patients and doctors (%) by level of satisfaction.

% Patient% Doctor

9 months

6 months

3 months

1 months

0 10 20 30 40 50 60 70 80 90 100

Product features Purpose Wrinkle TreatmentProduct name HYABELL® BASICIndications medium wrinkles,

lip contourConcentration 16 mg/ml Lidocaine content 0.3%Crosslinking agent BDDEPackaging 1 x 1.0 ml Needle size 27G Estimated duration 6-9 monthsVolumising effect ••••Depth of injection middle to deep dermis

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20 mg/ml hyaluronic acid gel with 0.3% lidocaine

– for deep dermis,correction of deep folds

DEEP

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Aesthetic satisfaction1 to 12 months post-injection. Distribution of patients and doctors (%) by level of satisfaction.

% Patient% Doctor

12 months

6 months

3 months

1 months

0 10 20 30 40 50 60 70 80 90 100

Product features Purpose VolumisationProduct name HYABELL® DEEPIndications deep wrinkles,

especially contour of the faceConcentration 20 mg/ml Lidocaine content 0.3%Crosslinking agent BDDEPackaging 1 x 1.0 ml Needle size 27G Estimated duration 9-12 monthsVolumising effect •••••Depth of injection deep dermis / hypodermis

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24 mg/ml hyaluronic acid gel with 0.3% lidocaine

– for subcutaneous tissue,correction of deep folds and facial volumising

ULTRA

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Aesthetic satisfaction1 to 12 months post-injection. Distribution of patients and doctors (%) by level of satisfaction.

% Patient

12 months

6 months

3 months

1 months

0 10 20 30 40 50 60 70 80 90 100

% Doctor

Product features Purpose VolumisationProduct name HYABELL® ULTRAIndications very deep wrinkles,

face contouring, volumisingConcentration 24 mg/ml Lidocaine content 0.3%Crosslinking agent BDDEPackaging 1 x 1.0 ml Needle size 27G Estimated duration 12-14 monthsVolumising effect ••••••Depth of injection hypodermis / epiperiostal

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HYABELL® – TreatmentHYABELL® products are made of non-animal origin hyaluronic acid andcontain 0.3% lidocaine. They are medical devices de signed to be injectedby a doctor experienced specifically in the techniques of filling facial wrinkles by injection in the dermis and sub cutaneous tissue.

The area to be treated must be properly cleaned with disinfectant solutionbefore the injection. The treatment is easy and quick. Thanks to its softextrusion force and the use of thin needles provided, the injections areprecise, simple and almost painless. Depending on the sensiti vity of thepatient, an anaesthesia cream may be appropriate. On certain sensi tiveareas such as lips, it is recommended to give a local nerve-blocking anaesthesia.

Using enclosed thin needles (27G) HYABELL® products can be injectedslowly in the mid or deep dermis or subcutaneous tissue by linear with -drawal technique (tunnel technique), by serial puncture- or fan-techniqueor by a combination of these techniques. The treated zone must be slightly massaged after injection in order to spread the implant.

The quantity of HYABELL® products to be used depends on the de pres sion to fill and the desired effect.

With HYABELL® products, optimal volumising effect is easy to obtain, with less quantity to be injected. No overcorrection is needed. Please read the packing insert for further information.

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SUMMARYHYABELL® fillers have considerably better visco-elastic properties and softer extrusion forces than other hyaluronic acid dermal fillersavailable. This is mainly due to the innovativemonophasic particle technology (MPT) used inthe production process of HYABELL® fillers.

The optimized physical properties ofHYABELL® fillers allow better clinical results.

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Frequently asked questionsHow long do the results last?HYABELL® persists in the dermis for at least 6 to 14 months. The highdegree of crosslink ing supports a slower absorption of HYABELL® in thetissue. The durability of HYABELL® in the skin varies according to skintype, age and the way of life of the patient as well as treated area andinjection technique. It may be necessary to renew the treatment partially in order to opti mise the results and durability of the correction.

Are there any precautionary measures to be considered?• After the injection, it is recommended to apply ice or a cooling

device on the treated areas in order to decrease the transitory inflammation due to injection.

• Make-up should be avoided during the first twelve hours followingthe injection.

• The client must also avoid saunas, steam bath, UV rays and exposure to cold during 10 days following the injection.

• In the event of prolonged exposure to the sun, a sun block should be applied to the treated areas.

Are there contra-indications?HYABELL® should not be used on pregnant women or while breast feeding. It should not be in jected in a patient presenting an auto-immunedisease, antecedents of allergy or over-sensi tiveness to the hyaluronicacid, or a immunotherapeutic treatment. HYABELL® should not be injectedinto inflammatory and/or infectious skin (acne, herpes, impetigo…), skinprone to develop hypertrophic scars. It should not be used in conjunctionwith any laser treatment, chemical peeling or dermabrasion. A prior consultation with the patient will enable you to know the medicalhistory, especially previous aesthetic treatments (like injections) and todetermine if HYABELL® is suitable to this individual case. For more information please refer to the packaging insert of HYABELL®.

Are there undesirable effects?As with all skin fillers swelling and/or redness, with or without associatedpain, may occur after the injection. These generally disappear within a fewhours, days or in some cases within a week. Some rare cases of necrosis,abscess, granuloma or of over-sensitivity have been described in thescientific literature after injections of hyaluronic acid. Continuation of thesereactions or appearance of any other side effects must be reported to thepractitioner by the patient as soon as possible in order to resolve it byappropriate treatment. The distributor should also be in formed about thisincident. Before treatment, please inform the patient about the potentialside effects related to this injectable implant.

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References1- Klein AW, Elson ML, The history of substances for soft tissue augmentation, Dermatol Surg, 2000, 26: 1096-1105.

2- Baumann L, Dermal fillers, J Cosmetic Dermatol, 2005, 3: 249-250.

3- Coleman S and the Plastic Surgery Educational Foundation DATA Committee, Cross-linked hyaluronic acid fillers, Plast Reconstr Surg, 2006, 117(2), 661-665.

4- Tezel A, Fredrickson GH, The science of hyaluronic acid dermalfillers, Journal of Cosmetic and Laser Therapy, 2008, 10: 35-42.

5- Larsen NE, Pollak CT, Reiner K, Leshchiner E, Balazs EA, Hylan gel biomaterial: dermal und immunologic compatibility, J Biomed Mater Res, 1993, 27(9), 1129-1134.

6- Klein AW, Techniques for soft tissue augmentation, Am J Clin Dermatol, 2006, 7: 107-120.

7- Duranti F, Salti G, Bovani B, Calandra M, Rosati ML, Injectable hyaluronic acid gel for soft tissue augmentation: A clinical and histological study; Dermatol Surg 1998; 12:1317-25.

8- Friedman PM, Mafong EA, Kauvar ANB, Geronemus RG, Safety data of injectable nonanimal stabilized hyaluronic acid gel for soft tissue augmentation, Dermatol Surg, 2002, 28: 491-494.

9- DeLorenzi, C, Weinberg M, Solish N, Swift A, A multicenter study of the efficacy and safety of subcutaneous nonanimal stabilized hyaluronic acid in aesthetic facial contouring: Interim report, Dermatol Surg, 2006, 32: 205-211.

10- Brody HJ, Use of hyaluronidase in the treatment of granulomatous hyaluronic acidreaction or unwanted hyaluronic acid misplacement, Dermatol Surg, 2005, 31: 893-897.

11- Glaich SA, Cohen JL, Goldberg LH, Injection necrosis of the glabella: protocol for pre-vention and treatment after use of dermal fillers, Dermatol Surg, 2006, 32(2): 285-290.

12- Weidmann MJ, Varioderm – A new generation of hyaluronic acid, EuropeanDermatology, 2008, 3: 50-53.

13- Weidmann MJ, New Hyaluronic acid filler for sub-dermal and long-lasting volume restoration of the face, European Dermatology, 2009, 1: 65-68.

14- Alsoufi A, New and innovative developments in hyaluronic acid fillers for lip enhancement and contouring, European Dermatology, 2010, 5: 50-53.

15- Alsoufi A, Hyaluronic Acid Fillers: A retrospective analysis of 108 cases of patients re -ceiving hyaluronic acid filler for long-lasting volume restoration on the face, Prime, 2011, 1(5):62-64.

16- Mieles ER, Hand Rejuvenation with Hyaluronic Acid, Prime, 2012, 2(2), 76-77.

17- Bingöl AÖ, Dogan A, Physical Properties of Hyaluronic Acid Fillers and their Relevancefor Clinical Performance, Magazin für ästhetische Chirurgie, 2012, 2, 6-12.

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ADODERM GmbH • Elisabeth-Selbert-Strasse 5 • D-40764 Langenfeld • Germanyt +49 (0) 2173 / 101 91 80 • f +49 (0) 2173 / 101 91 82

info@adoderm.com • www.adoderm.com

D.75

.71/01

HYABELL® a product range by

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